Management of hepatitis C virus infection in HIV/HCV co-infected patients: Clinical review

Table 4 Morbidity and mortality with PEG-IFN + RBV: results of three large trials

Parameter	Sub-parameter	ACTG (n = 66)	APRICOT (n = 286)	RIBAVIC (n = 194)
Treatment related adverse events	Influenza like symptoms	31 (47)		172 (89)
	Fatigue		128 (44)
	Pyrexia		128 (44)
	Headache		111 (39)
	Myalgia		103 (36)
	Nausea		85 (30)
	Diarrhea		81 (28)
	Depression	7 (11)	76 (26)	46 (24)
	Weight loss		82 (28	46 (24)
	Injection site reaction			44 (21)
	Anorexia			38 (20)
	Irritability			32 (16)
	Bronchitis/cough			26 (13)
	Insomnia		76 (26)	19 (10)
	Elevated lipase/amylase	9 (14)
	Glucose: high or low	19 (28)
HIV-related adverse events	Lipodystrophy			37 (19)
	Oral candidiasis		2 (< 1)	30 (15)
	AIDS defining event		2 (< 1)
Specific serious adverse events	Psychiatric disorders			8 (4)
	Liver failure		1 (< 1)	4 (2)
	Liver decompensation		5 (2)
	Pneumonia/sepsis		2 (1)	6 (3)
	Symptomatic increased lactate		4 (1)	9 (5)
	Pancreatitis		2 (1)
	Lactic acidosis	0 (0)	2 (1)
	ELAT > 10 ULN	20 (30)		16 (8)
	Neutropenia < 500/μL	5 (8)		10 (5)
	Anemia	2 (3)	6 (2)
	Thrombocytopenia	1 (2)	1 (< 1)
	Drug abuse		4 (1)
	Deep vein thrombosis		3 (1)
	Bacterial infection		3 (1)
	Gastroenteritis		2 (1)
Any serious event	Total		50 (17)	68 (35)
	Treatment-related		24 (8)	30 (15)
Deaths	Total	1 (2)	4 (1)	5 (3)